Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context
Introduction: Lab-diagnosis of hepatitis C virus (HCV) is based on detecting specific antibodies by enzyme immuno-assay (EIA) or chemiluminescence immuno-assay (CIA). Center for Disease Control reported that signal-to-cut-off (s/co) ratios in anti-HCV antibody tests like EIA/CIA can be used to predi...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2015-01-01
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| Series: | Asian Journal of Transfusion Science |
| Subjects: | |
| Online Access: | http://www.ajts.org/article.asp?issn=0973-6247;year=2015;volume=9;issue=2;spage=185;epage=188;aulast=Tiwari |
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| author | Aseem K Tiwari Prashant K Pandey Avinash Negi Ruchika Bagga Ajay Shanker Usha Baveja Raina Vimarsh Richa Bhargava Ravi C Dara Ganesh Rawat |
| author_facet | Aseem K Tiwari Prashant K Pandey Avinash Negi Ruchika Bagga Ajay Shanker Usha Baveja Raina Vimarsh Richa Bhargava Ravi C Dara Ganesh Rawat |
| author_sort | Aseem K Tiwari |
| collection | DOAJ |
| description | Introduction: Lab-diagnosis of hepatitis C virus (HCV) is based on detecting specific antibodies by enzyme immuno-assay (EIA) or chemiluminescence immuno-assay (CIA). Center for Disease Control reported that signal-to-cut-off (s/co) ratios in anti-HCV antibody tests like EIA/CIA can be used to predict the probable result of supplemental test; above a certain s/co value it is most likely to be true-HCV positive result and below that certain s/co it is most likely to be false-positive result. A prospective study was undertaken in patients in tertiary care setting for establishing this "certain" s/co value. Materials and Methods: The study was carried out in consecutive patients requiring HCV testing for screening/diagnosis and medical management. These samples were tested for anti-HCV on CIA (VITROS ® Anti-HCV assay, Ortho-Clinical Diagnostics, New Jersey) for calculating s/co value. The supplemental nucleic acid test used was polymerase chain reaction (PCR) (Abbott). PCR test results were used to define true negatives, false negatives, true positives, and false positives. Performance of different putative s/co ratios versus PCR was measured using sensitivity, specificity, positive predictive value and negative predictive value and most appropriate s/co was considered on basis of highest specificity at sensitivity of at least 95%. Results: An s/co ratio of ≥6 worked out to be over 95% sensitive and almost 92% specific in 438 consecutive patient samples tested. Conclusion: The s/co ratio of six can be used for lab-diagnosis of HCV infection; those with s/co higher than six can be diagnosed to have HCV infection without any need for supplemental assays. |
| first_indexed | 2024-12-23T23:20:20Z |
| format | Article |
| id | doaj.art-af76f90445134a819ca1718b1fe76070 |
| institution | Directory Open Access Journal |
| issn | 0973-6247 1998-3565 |
| language | English |
| last_indexed | 2024-12-23T23:20:20Z |
| publishDate | 2015-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Asian Journal of Transfusion Science |
| spelling | doaj.art-af76f90445134a819ca1718b1fe760702022-12-21T17:26:21ZengWolters Kluwer Medknow PublicationsAsian Journal of Transfusion Science0973-62471998-35652015-01-019218518810.4103/0973-6247.154259Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian contextAseem K TiwariPrashant K PandeyAvinash NegiRuchika BaggaAjay ShankerUsha BavejaRaina VimarshRicha BhargavaRavi C DaraGanesh RawatIntroduction: Lab-diagnosis of hepatitis C virus (HCV) is based on detecting specific antibodies by enzyme immuno-assay (EIA) or chemiluminescence immuno-assay (CIA). Center for Disease Control reported that signal-to-cut-off (s/co) ratios in anti-HCV antibody tests like EIA/CIA can be used to predict the probable result of supplemental test; above a certain s/co value it is most likely to be true-HCV positive result and below that certain s/co it is most likely to be false-positive result. A prospective study was undertaken in patients in tertiary care setting for establishing this "certain" s/co value. Materials and Methods: The study was carried out in consecutive patients requiring HCV testing for screening/diagnosis and medical management. These samples were tested for anti-HCV on CIA (VITROS ® Anti-HCV assay, Ortho-Clinical Diagnostics, New Jersey) for calculating s/co value. The supplemental nucleic acid test used was polymerase chain reaction (PCR) (Abbott). PCR test results were used to define true negatives, false negatives, true positives, and false positives. Performance of different putative s/co ratios versus PCR was measured using sensitivity, specificity, positive predictive value and negative predictive value and most appropriate s/co was considered on basis of highest specificity at sensitivity of at least 95%. Results: An s/co ratio of ≥6 worked out to be over 95% sensitive and almost 92% specific in 438 consecutive patient samples tested. Conclusion: The s/co ratio of six can be used for lab-diagnosis of HCV infection; those with s/co higher than six can be diagnosed to have HCV infection without any need for supplemental assays.http://www.ajts.org/article.asp?issn=0973-6247;year=2015;volume=9;issue=2;spage=185;epage=188;aulast=TiwariAnti-hepatitis C virus testsCenter for Disease Controlchemiluminescence immuno-assaypolymerase chain reactiontesting algorithm |
| spellingShingle | Aseem K Tiwari Prashant K Pandey Avinash Negi Ruchika Bagga Ajay Shanker Usha Baveja Raina Vimarsh Richa Bhargava Ravi C Dara Ganesh Rawat Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context Asian Journal of Transfusion Science Anti-hepatitis C virus tests Center for Disease Control chemiluminescence immuno-assay polymerase chain reaction testing algorithm |
| title | Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context |
| title_full | Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context |
| title_fullStr | Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context |
| title_full_unstemmed | Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context |
| title_short | Establishing a sample-to cut-off ratio for lab-diagnosis of hepatitis C virus in Indian context |
| title_sort | establishing a sample to cut off ratio for lab diagnosis of hepatitis c virus in indian context |
| topic | Anti-hepatitis C virus tests Center for Disease Control chemiluminescence immuno-assay polymerase chain reaction testing algorithm |
| url | http://www.ajts.org/article.asp?issn=0973-6247;year=2015;volume=9;issue=2;spage=185;epage=188;aulast=Tiwari |
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